Senior Quality Engineer
Posted on: January 12, 2022
ITW Medical manufactures and sells components and finished devices
for use in medical Imaging, Filtration, Infusion, and Minimally
ITW Medical is comprised of three strong medical product brands -
Coeur, Filtertek & Precise - situated to proactively meet the needs
of customers in the marketplace. Coeur is a leading provider of
disposable medical products used in diagnostic imaging and other
medical procedures. The Filtertek product line is comprised of
custom plastic insert molded filtration and flow control components
for global OEM medical device customers. Precise Biomedical is a
service company providing maintenance and repair of power injectors
used for imaging procedures
This position will report to ITW Medicals Quality Manager - Hebron.
The individual will be responsible for validations, scrap reduction
and continuous improvement activities. The individual will ensure
that projects are implemented, internal/external quality issues are
investigated, and root cause and corrective/preventive actions are
identified and executed. This position will be primarily
responsible for the Hebron, Ill location.
Duties And Responsibiities
New Product Development
This position will be heavily involved in validation and
verification of new products, expanded processes, and continuous
improvement in all areas of the business. Given the avalanche of
new business, this position will be heavily engaged with customers.
In addition to validation protocols and reports, this position will
be responsible for Gage MSA.
Participate in creation and maintain Failure Modes and Effects
Assist in documenting development work including supporting writing
specifications for manufacturing, identifying and/or evaluating
scientific test results, and working with Design team to ensure
Follow-up Drawings are coordinated.
Support Implementation of IQ, OQ, PQ.
Ensure timely and conclusive validation protocol and report
Update existing inspection plans, test methods, and standard
Conduct sample size determination, statistical analysis, training,
and root cause analysis
Assist in process optimization and work with Operations to
implement CpKs and use of process controls.
Work with Quality, OPS, and Engineering teams and help implement
improved ECN Processing
Support and Actively contribute to various manufacturing projects
such as process development, cost reduction and quality improvement
Perform routine engineering assignments of related tasks which are
typically a focused portion of larger projects.
Support cross-functional teams in continuous quality improvement
projects, in particular, in scrap reduction and identification and
elimination of non-value-added activities.
Take lead in collection, review, analysis and trending of quality
indicators for monthly and quarterly reviews.
Manage and contribute to problem solving teams using standardized
investigation processes/tools. (This includes customer complaint
investigation and response.)
Develop understanding of Test Equipment and identify tester
Participate in the Internal Audit process and assist in addressing
observations and support Environmental auditing.
Participate in customer and regulatory body audits
Other tasks and duties assigned
Position Skills and Experience Requirements:
To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
- Bachelors degree (required) in Biomedical Engineering field
- 5+ years related experience (required) in Medical Devices
- Ability to perform routine design and engineering tasks with
- Solid understanding of engineering and mathematics
- Expertise in the application of statistics and the ability to
talk with customers with a high level of understanding of
statistical application and requirements.
- Successful experience using Sharepoint and other electronic
data filing/management/ processing software.
- Ability to interpret product requirements from drawings,
specifications, blueprints, etc. and to identify and drive
corrections of inconsistencies or inaccuracies in same
- Able to command use of inspection and measuring instruments
such as calipers, micrometers, and tensile strength testers
- Highly motivated, detail-oriented, eager to drive needed change
in the organization
- Demonstrated use of strong analytical, problem solving, and
teamwork skills in a leadership role
- Able to follow and to provide instructions in all formats:
written, verbal, and electronic.
- Excellent time management, prioritization abilities, and strong
project management skills
- Ability to develop, implement, and present strategies to gain
- Strong analytical skills, with 80/20 mindset
- Ability to work with and manage complexity/change such that
implementation is simplified
- Demonstrated ability to analyze data and make sound,
- Excellent interpersonal, communication, and presentation
- Ability to generate respect and trust from staff and external
constituencies along with the ability to work collaboratively with
colleagues and staff to create a results-driven, team-oriented,
- Personally driven and able to motivate others to excel
- Ability to use MS Office Tools such as Word, Excel, Project,
Access and MiniTab.
ITW offers a competitive compensation and benefits package,
including competitively priced medical and dental coverage the
first of the month following hire, free life insurance, paid
vacation and holidays, and immediate 401k matching. Additional
retirement savings contribution (above and beyond 401k) is awarded
at no cost after one year.
ITW Medical is an equal opportunity, equal employment, affirmative
action employer. We strive to create a diverse and inclusive work
environment where everyone is welcome to contribute their unique
talents and ideas. We encourage applications from females, males,
disabled/protected or other veterans, persons with disabilities,
all races and ethnicities, sexual orientations and gender
identities. Reasonable accommodation will be made to enable persons
with disabilities to apply and to perform the essential job
functions. If you require assistance with completing an
application, please reply that you require assistance.by
Keywords: Itw, Elgin , Senior Quality Engineer, Engineering , Hebron, Illinois
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